Anvil assemblies and delivery systems

ABSTRACT

An anvil assembly suitable for trans-oral delivery includes an anvil head configured to receive a suture that secures the anvil head in a delivery position and is separable from the anvil head following delivery of the anvil assembly. An anvil delivery assembly includes the anvil assembly, a delivery assembly secured to the anvil assembly, and a suture selectively secured to the anvil assembly for securing the anvil assembly in a delivery position and retrieving the anvil assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Divisional Application which claims thebenefit of and priority to U.S. patent application Ser. No. 15/974,087,filed May 8, 2018, which is a Continuation Application claiming thebenefit of and priority to U.S. patent application Ser. No. 14/790,227,filed on Jul. 2, 2015, now U.S. Pat. No. 9,974,536, issued May 22, 2018,the entire content of each of which are being incorporated herein byreference.

BACKGROUND Technical Field

The present disclosure relates to an anvil assemblies for use with asurgical stapling device. More particularly, the present disclosurerelates to a delivery system for trans-oral delivery of the anvilassemblies.

Background of Related Art

Trans-oral delivery systems for delivering an anvil assembly to asurgical site, e.g., the stomach, typically include a guide suturethreaded through one or more openings in the head of the anvil assemblyto facilitate trans-oral insertion of the anvil assembly. The guidesuture, which includes ends that remain external of the patient's mouth,may be used by the surgeon to dislodge the anvil assembly if the anvilassembly becomes stuck during trans-oral delivery of the anvil assemblyand/or to retrieve the anvil assembly in the event of a patientemergency, e.g., cardiac arrest. Improved methods for securing the guidesuture to the anvil assembly to facilitate detachment of the guidesuture from the anvil assembly once the anvil assembly is delivered tothe surgical site and/or the stapling procedure has been performed aredesirable.

SUMMARY

An anvil delivery system is provided. The anvil delivery system includesa delivery assembly an anvil assembly selectively securable to thedelivery assembly and including a center rod assembly selectivelysecurable to the delivery assembly and a head assembly pivotally securedto the center rod assembly between a first tilted position and anoperative position. The anvil delivery system further including a sutureextending from the anvil delivery system through the head assembly anddistally of the head assembly, wherein the suture retains the headassembly in the first tilted position.

In embodiments, the head assembly includes a housing that defines afirst proximal opening and a second proximal opening, the sutureextending through each of the first and second proximal openings. Thedelivery assembly may include a flexible member and an adapter. Thesuture may extend through the adapter. The suture may be frictionallysecured between the flexible member and the adapter. The suture mayextend from the first proximal opening through the adapter and to thesecond proximal opening. A first portion of the suture may cross over asecond portion of the suture between the head assembly and the adapter.The suture may include a loop extending distally of the head assembly.The head assembly may be movable to a second tilted position oppositethe first tilted position.

Also provided is a method of securing an anvil assembly in a firsttilted position. The method includes receiving a first end of a suturethrough a first opening in a head assembly of an anvil assembly,receiving the first end of the suture through a bore in an adaptersecured to a center rod assembly of the anvil assembly, receiving thefirst end of the suture back through a second opening in the headassembly, and tying the first end of the suture to a second end of thesuture adjacent the head assembly.

In embodiments, the method further includes moving the head assemblyrelative to the center rod assembly prior to tying the first end of thesuture to the second end of the suture. Moving the head assemblyrelative to the center rod assembly may include pivoting the headassembly to a first tilted position. Receiving the first end of thesuture through a first opening may include receiving the first end ofthe suture into a first distal opening and out a first proximal opening.Receiving the first end of the suture through a second opening mayinclude receiving the first end of the suture into a second proximalopening and out of a second distal opening.

Another method of securing an anvil assembly in a first tilted positionis also provided. The method includes receiving a first end of a suturethrough a first opening in a head assembly of an anvil assembly,receiving a second end of the suture through a second opening in thehead assembly, receiving the first and second ends of the suture througha bore in an adapter, and securing the adapter to a flexible member suchthat the suture is secured within the bore.

In embodiments, receiving the first and second ends of the suturethrough a bore includes receiving the first end of the suture through afirst bore in a first direction and receiving the second end of thesuture through the first bore in a second direction, then receiving thefirst end of the suture through a second bore in the second directionand receiving the second end of the suture through the second bore inthe first direction. Securing the adapter to the flexible member mayinclude receiving a first end of the adapter within an open end of theflexible member.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed anvil assembly and anvilassembly delivery system are disclosed herein with reference to thedrawings wherein:

FIG. 1 is a perspective view of a surgical stapling device including anembodiment of an anvil assembly according to the present disclosure;

FIG. 2 is a first perspective side view of the anvil assembly of FIG. 1;

FIG. 3 is a second perspective side view of the anvil assembly shown inFIGS. 1 and 2;

FIG. 4 is an exploded side view of the anvil assembly of FIGS. 1-3;

FIG. 5 is an end view of the anvil assembly of FIGS. 1-4;

FIG. 6 is a cross-sectional side view of a distal end of the tilt anvilassembly of FIGS. 1-6 taken along line 6-6 of FIG. 5;

FIG. 7 is a cross-sectional side view of a distal end of the anvilassembly of FIGS. 1-6 taken along line 7-7 of FIG. 5;

FIG. 8 is an enlarged side view of the cam latch member of the anvilassembly of FIGS. 1-7;

FIG. 9 is a top view of the anvil assembly of FIGS. 1-7 supported on ananvil delivery system;

FIG. 10 is an enlarged exploded view of the anvil delivery system ofFIG. 9;

FIG. 11 an enlarged top view of the anvil delivery system of FIGS. 9 and10, including the anvil assembly of FIGS. 1-7;

FIG. 12 is a cross-sectional side view of the anvil assembly and anvilassembly delivery system of FIG. 11 taken along lines 12-12 of FIG. 11;

FIG. 13 is a cross sectional side view of the anvil assembly of FIGS.1-7, in a pre-fired tilted position supported on the anvil deliverysystem of FIGS. 9-12;

FIG. 14 is an enlarged view of the indicated area of detail shown inFIG. 13;

FIG. 15 is an illustration of the anvil assembly and anvil deliverysystem of FIGS. 11 and 12 being inserted trans-orally into a patient;

FIG. 16 is an enlarged side view of the distal head portion of thesurgical stapling device of FIG. 1 with the anvil assembly removed;

FIG. 17 is an enlarged side view of the distal head portion of thesurgical stapling device of FIG. 1 with the anvil assembly of FIGS. 1-7received thereon;

FIG. 18 is an enlarged cross-sectional side view of the distal headportion of the surgical stapling device of FIG. land the anvil assemblyof FIGS. 1-7 in a pre-fired non-tilted operative position;

FIG. 19 is an enlarged cross-sectional side view of the distal headportion of the surgical stapling device of FIG. land the anvil assemblyof FIGS. 1-7 in a post-fired non-titled operative position;

FIG. 20 is an enlarged cross-sectional side view of the distal end ofthe anvil assembly of FIGS. 1-7 in the post-fired operative position;

FIG. 21 is an enlarged cross-sectional side view of the distal end ofthe anvil assembly of FIGS. 1-7 in a post-fired tilted position;

FIG. 22 is a cross-sectional side view of the anvil assembly of FIGS.1-7 in a post-fired tilted position supported on an anvil retainer ofthe surgical instrument of FIG. 1;

FIG. 22A is another cross-sectional side view of the anvil assembly ofFIGS. 1-7 in a post-fired tilted position supported on an anvil retainerof the surgical instrument of FIG. 1

FIG. 23 is an enlarged view of the indicated area of detail shown inFIG. 22A;

FIG. 24 is a side view of the anvil assembly of FIG. 22 supported on theanvil retainer of the surgical stapling device of FIG. 1;

FIG. 25 is a perspective side view of an anvil assembly according toanother embodiment of the present disclosure in an operative position;

FIG. 26 is a perspective bottom view of the anvil assembly of FIG. 25,in a first tilted position and with a backup plate/cutting ring assemblyremoved;

FIG. 27 is a top view of the anvil assembly of FIG. 25 and a distalportion of the anvil delivery system of FIG. 11 with parts separated,and a suture as the suture is secured to the anvil assembly and anvildelivery system in a first configuration;

FIG. 28 is a top view of the anvil assembly, anvil delivery assembly,and suture of FIG. 27, with the anvil delivery system secured to theanvil assembly and the suture secured to the anvil assembly and theanvil delivery system in the first configuration;

FIG. 29 is a top view of the anvil assembly of FIG. 25 and a distalportion of the anvil delivery system of FIG. 11 with parts separated,and a suture as the suture is secured to the anvil assembly and anvildelivery system in a second configuration;

FIG. 30 is a top view of the anvil assembly, anvil delivery assembly,and suture of FIG. 29, with an adapter of the anvil delivery systemsecured to the anvil assembly and as the suture is secured to the anvilassembly and the anvil delivery system in the second configuration;

FIG. 31 is a top view of the anvil assembly, anvil delivery assembly,and suture of FIG. 29, with the anvil delivery system secured to theanvil assembly and the suture secured to the anvil assembly and theanvil delivery system in the second configuration;

FIG. 32 is a top view of the anvil assembly, anvil delivery assembly,and suture of FIG. 29, with the anvil delivery system secured to theanvil assembly and the suture secured to the anvil assembly and theanvil delivery system in a third configuration; and

FIG. 33 is a perspective side view of the anvil assembly, anvil deliveryassembly, and suture of FIG. 32, further including a suture reel.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed anvil assembly delivery systemwill now be described in detail with reference to the drawings in whichlike reference numerals designate identical or corresponding elements ineach of the several views. Throughout this description, the term“proximal” will refer to the portion of the instrument closest to theoperator and the term “distal” will refer to the portion of theinstrument furthest from the operator.

FIG. 1 illustrates an embodiment of a surgical stapling deviceconfigured for use with tilt anvil assemblies and anvil delivery systemsaccording to the present disclosure. Although the anvil assemblies andanvil delivery systems of the present disclosure will be described withreference to surgical stapling device 10, it is envisioned that theanvil assemblies and anvil delivery systems may be modified for use withalternative surgical stapling devices.

Briefly, the surgical stapling device 10 includes a proximal handleassembly 12, an elongated central body portion 14 including a curvedelongated outer tube 14 a, and a distal head portion 16. Alternately, insome surgical procedures, e.g., the treatment of hemorrhoids, it isdesirable to have a substantially straight, shortened, central bodyportion. The length, shape and/or the diameter of the body portion 14and the distal head portion 16 may also be varied to suit a particularsurgical procedure.

With reference still to FIG. 1, the handle assembly 12 includes astationary handle 18, a firing trigger 20, a rotatable approximationknob 22 and an indicator 24. A pivotally mounted trigger lock 26 isfastened to the handle assembly 12 and is manually positioned to preventinadvertent firing of the stapling device 10. The indicator 24 ispositioned on the stationary handle 18 and includes indicia, e.g., colorcoding, alpha-numeric labeling, etc., to identify to a surgeon whetherthe device is approximated and is ready to be fired. The head portion 16includes an anvil assembly 110 and a shell assembly 31. For a moredetailed discussion of an exemplary surgical stapler, please refer tocommonly owned U.S. Pat. No. 7,364,060 to Milliman, the content of whichis incorporated herein by reference in its entirety.

Referring now to FIGS. 2-7, an anvil assembly according to an embodimentof the present disclosure is shown generally as anvil assembly 110. Theanvil assembly 110 is shown in a non-titled position or operativeposition. The anvil assembly 110 includes a head assembly 112 and acenter rod assembly 114. The head assembly 112 includes a post 116, ahousing 118, a backup member or plate 120, a cutting ring 122, a cuttingring cover 123, an anvil plate 124, a spacer or washer 125, a cam latchmember 126, and a retainer member 127. The post 116 is monolithicallyformed with and centrally positioned within the housing 118.Alternately, the housing 118 and the post 116 may be formed separatelyand fastened together using a known fastening technique, e.g., welding.

As will be discussed in further detail below, the housing 118 includesopenings 119 a, 119 b sized and dimensioned to receive one or moresutures “S”. During use, a first suture “S₁” (FIG. 9) is insertedthrough openings 119 a and is used to retain the head assembly 112 in aretracted or first tilted position (FIG. 9) during insertion of theanvil assembly 110 within a patient. A second suture “S₂” (FIG. 9) isinserted through the openings 119 b. The second suture “S₂” isconfigured to facilitate guiding the anvil assembly 110 trans-orallywithin a patient. During trans-oral insertion of the anvil assembly 110,the second suture “S₂” extends from the mouth “M” (FIG. 15) of patient,permitting the anvil assembly 110 to be retrieved trans-orally.

With reference still to FIGS. 2-7, the anvil plate 124 is supported inan outer annular recess 128 of the housing 118 and includes a pluralityof staple deforming pockets 130 for receiving and deforming staples. Atleast one tab 124 a extends radially outwardly from the anvil plate 124and is received within a cutout 132 formed in an outer rim of thehousing 118. The tab 124 a and the cutout 132 function to align orproperly position the anvil plate 124 within the annular recess 128 ofthe housing 118.

With particular reference to FIGS. 6 and 7, the head assembly 112 willbe described in detail. The backup plate 120 includes a central opening134 which is positioned about the post 116 within an inner annularrecess 136 of the housing 118 between the post 116 and the outer annularrecess 128. The backup plate 120 includes a raised platform 120 a. Thecutting ring 122 includes an opening 122 a having a configurationsubstantially the same as the platform 120 a. Although the platform 120a is illustrated as having a circular shape, other configurations areenvisioned, e.g., square, rectangular, triangular, etc. In oneembodiment, the cutting ring 122 is formed from polyethylene and isfixedly secured to the backup plate 120 using, for example, an adhesive,to form a backup plate/cutting ring assembly. The backup plate 120 isformed from a hard material, e.g., a metal. Alternately other materialsof construction may be used to construct the backup plate 120 and thecutting ring 122. Further, the backup plate 120 and the cutting ring122, in the alternative, can be formed as a single or unitary structure.

Still referring to FIGS. 6 and 7, a cutting ring cover 123 is secured toan outwardly facing or proximal surface of the cutting ring 122 using,for example, an adhesive. In one embodiment, the cutting ring cover 123is formed from a material or materials, having a hardness greater thanthat of the cutting ring, e.g., mylar. In one embodiment, the cuttingring cover 123 includes two layers of mylar (not shown) which are joinedtogether using an adhesive and a polypropylene coating. Alternately, thecutting ring 122 does not include a cover. The cutting ring 122 and thebackup plate 120 are slidably mounted about the post 116. The backupplate 120 includes a pair of inwardly extending fingers 138 which willbe described in further detail below.

With reference still to FIGS. 6 and 7, the retainer member 127 ispositioned in the inner annular recess 136 between the backup plate 120and a back wall 118 a of the housing 118. In one embodiment, theretainer member 127 is annular and includes a plurality of deformabletabs 127 a which engage a rear surface of the backup plate 120. Theretainer member 127 prevents the backup plate 120 and the cutting ring122 from moving or being pushed into the inner annular recess 136 of thehousing 118 until a predetermined force sufficient to deform the tabs127 a has been applied to the backup plate/cutting ring assembly. Thepredetermined force can be close to but is less than the force appliedby an annular cutting blade of a surgical stapling device when itengages, for example, the cutting ring of the anvil assembly 110. In oneembodiment by way of example, the predetermined force is between aboutten pounds and about ninety pounds and can be about thirty (30) pounds.When the predetermined force is reached, e.g., during cutting of tissue,the backup plate 120 is urged into the inner annular recess 136 andcompresses the retainer member 127.

It is envisioned that other crushable, deformable, collapsible ormovement restricting members may be used to retain the backupplate/cutting ring assembly in a fixed position until a predeterminedforce has been applied to the backup plate/cutting ring assembly. Anexemplary retaining member is described in commonly owned U.S. patentapplication Ser. No. 14/078,766, the content of which is incorporated byreference herein in its entirety.

Turning back to FIG. 4, the anvil center rod assembly 114 includes acenter rod 152, a plunger 154, and plunger spring 156. A first end ofcenter rod 152 includes a pair of arms 159 which define a cavity 159 a.Each arm 159 has a transverse throughbore 158 which is aligned with acentral longitudinal axis of the center rod 152. Alternately, thethroughbores 158 can be offset from the longitudinal axis of the centerrod 152. The post 116 of the head assembly 112 is dimensioned to bepositioned within the cavity 159 a and also includes a transversethroughbore (not shown). A pivot member 162 pivotally secures the post116 to the center rod 152 via the throughbores 158 such that the headassembly 112 may be pivotally mounted to the anvil center rod assembly114.

Turning briefly to FIG. 8, the cam latch member 126 includes a body 126a having a throughbore 126 b. The throughbore 126 b is dimensioned toreceive the pivot member 162 such that the cam latch member 126 ispivotally mounted within the transverse slot 172 (FIG. 3) of the post116 about the pivot member 162. Referring now to FIGS. 3, 6 and 7, thecam latch member 126 includes a body portion 126 c which extendspartially from the transverse slot 172 of the post 116 and is positionedto be engaged by a finger 166 of the plunger 154. The body portion 126 cis configured such that the distance between the surface of the bodyportion 126 c and the throughbore 126 b increase in a clockwisedirection about the cam latch member 126. In this manner, the plunger154 is able to move forward as the cam latch member 126 rotates in aclockwise direction. Additionally, this configuration of the bodyportion 126 c permits the plunger 154 to be retracted as the cam latchmember 126 rotates in a counter-clockwise direction. The cam latchmember 126 also includes an edge 126 f, including a tab 126 b. A leadingportion of edge 126 f is configured to be urged into engagement with aninner periphery 120 b of the backup plate 120 by an engagement finger166 of the plunger 154 when the head assembly 112 is in its non-tiltedor operative position. The tab 126 g is configured to engage thebackwall 118 a of the housing 118 to prevent the cam latch member 126from rotating counter-clockwise relative to the housing 118.

With reference to FIG. 6, the plunger 154 is slidably positioned in abore 164 formed in the first end of center rod 152. The finger 166 ofthe plunger 154 is offset from the pivot axis of head assembly 112 andis biased into engagement with the body portion 126 c of the cam latch126. Engagement of the finger 166 with the body portion 126 c of the camlatch member 126 presses a leading portion of the edge 126 f against aninner periphery of the back plate 120 to urge the head assembly 112 toan operative or non-tilted position on the center rod 152.

Turning to FIG. 7, in the pre-fired operative position of the headassembly 112, i.e. when the head assembly 112 has been pivoted to itsnon-tilted position, the fingers 138 formed on the backup plate 120engage the protrusions 152 b adjacent the top surface 152 a of thecenter rod 152 to prevent the head assembly 112 from pivoting about thepivot member 162. The head assembly 112 may be tilted a degrees (FIG.13) relative to the anvil center rod assembly 114 in the pre-firedtilted position. In one embodiment, the head assembly 112 is tiltedabout seventy degrees (70°) in its pre-fired tilted position; however itshould be understood that tilting the head assembly 112 to other degreesis also contemplated. Titling of the head assembly 112 relative to theanvil center rod assembly 114 causes the body portion 126 c of the camlatch member 126 to engage the finger 166 of the plunger 154. As the camlatch member 126 rotates with the tilting of the head assembly 112, theplunger 154 is retracted within the bore 164 of the anvil center rodassembly 114, thereby compressing the spring 156. In this manner, thefinger 166 of the plunger 154 is distally biased against the bodyportion 126 c of cam latch member 126.

With reference to FIGS. 3 and 4, a second end of the center rod 152includes a bore 180 defined by a plurality of the flexible arms 182. Theflexible arms 182 each include an opening 182 a dimensioned to receive aprojection formed on or connected to a shell assembly 31 (FIG. 18).Alternatively, the openings 182 a may be configured to receive a suturefor permitting retrieval of the anvil assembly 110. The proximal ends ofeach of the flexible arms 182 include an internal shoulder 184dimensioned to releasably engage the shell assembly 31 of the surgicalstapling device 10 to secure the anvil assembly 110 to the surgicalstapling device 10. A plurality of splines 186 are formed about thecenter rod 152. The splines 186 function to align the anvil assembly 110with the staple holding portion of the surgical stapling device 10. Thecenter rod 152 also includes an annular recessed portion 190 tofacilitate grasping of the anvil assembly 110 by a surgeon with agrasper (not shown). The recessed portion 190 may include a roughened orknurled surface or an overmold to facilitate grasping of the anvilassembly 110.

With reference now to FIGS. 9-12, a system for delivering the anvilassembly 110 within a patient is shown generally as anvil deliverysystem 50. The anvil delivery system 50 includes a flexible tube ormember 52 and an adapter 62. The flexible tube 52 includes an open end52 a. The adapter 62 and the anvil assembly 110 are supported on theopen end 52 a of the flexible tube 52. The open end 52 a of the flexibletube 52 includes a throughbore 53 extending therethrough configured toreceive a locking pin 54. The open end 52 a further includes an opening55. The closed end 52 b of the flexible tube 52 is configured fortrans-orally receipt in a patient. The flexible tube 52 may includemarkings or other gradations 56 along the length thereof to indicate toa surgeon how much of the flexible tube 52 has been received within thepatient during insertion and/or to indicate the length of the flexibletube 52 remaining in the patient upon removal.

With particular reference to FIG. 10, the adapter 62 includes a firstend 62 a configured to be received within the open end 52 a of theflexible tube 52 and a second end 62 b configured to be received with inthe bore 180 formed in the center rod 152 of the anvil assembly 110. Thefirst end 62 a includes a series of annular rings 64 configured tofrictionally retain the first end 62 a of the adapter 62 within the openend 52 a of the flexible tube 52. The second end 62 b of the adapter 62includes a longitudinal guide member 66 configured to be receivedbetween the flexible arms 182 formed in the center rod 152 of the anvilassembly 110. In addition, the second end 62 b of the adapter 62 issized to allow the center rod 154 of the anvil assembly 110 to freelyslide into and off of the second end 62 b of the adapter 62. The adapter62 further includes a first throughbore 70 formed in a central hubportion 62 c as well as second and third throughbores 72, 74 formed inthe first end 62 a. The first throughbore 72 is configured to align withthe throughbore 53 formed in the open end 52 a of the flexible tube 52and is sized to receive the locking pin 54.

With particular reference now to FIGS. 10, 13 and 14, the anvil assembly110 is supported on the anvil delivery system 50. Securing the anvilassembly 110 to the anvil delivery system 50 requires that the firstsuture “S₁” is thread through the openings 119 a formed on the headassembly 112 such that the first and second ends “S_(1a)” “S_(1b)” ofthe suture “S₁” are positioned on opposites of the center rod 152. Next,the second end 62 b of the adapter 62 is positioned within thethroughbore 180 of the center rod 152 such that the longitudinal guide66 is received between two of the arm members 182. Each of the first andsecond ends “S_(1a)”, “S_(1b)” of the suture “S₁” is inserted throughthe opening 55 formed in the open end 52 a of the flexible tube 52. Thehead assembly 112 is then rotated to a first tilted position while firstand second ends “S_(1a)”, “S_(1b)” of suture “S₁” are pulled through theopening 55. The first end 62 a of the adapter 62 is then inserted intothe open end 52 a of the flexible member 52. The frictional contactbetween the annular rings 64 of the first end 62 a of the adapter 62 andan inner surface of the flexible tube 52 secures the adapter 62 to theflexible tube 52 and prevents the first suture “S₁” from loosening. Itis envisioned that more than one suture may be used to secure the headassembly 112 in a pre-fired tilted position.

With reference now to FIG. 15, a method for delivering the anvilassembly 110 to a surgical site within a patient will be described. Inone method, the anvil assembly 110 is provided in the first tiltedposition supported on the anvil delivery system 50 and ready fordelivery. Alternatively, a clinician secures the anvil assembly 110 tothe anvil delivery system 50 as discussed above. Once the anvil assembly110 has been secured to the flexible tube 52, the surgeon inserts theclosed end 52 b of the flexible tube 52 in the patient's mouth “M” andmoves the closed end 52 b along with the flexible tube 52 down throughesophagus “E” to a surgical site, i.e., the stomach “St”.

After insertion, the surgeon then makes a first incision “I₁” at thesurgical site (stomach “St” as shown) to create an inner access to theclosed end 52 b of the flexible tube 52 and then pulls the open end 52 bof the flexible tube 52 through the first incision “I₁”. In someprocedures it may be beneficial to pull the flexible tube 52 through theincision “I₁” until the center rod 152 of the anvil assembly 110advances through the first incision “I₁”. When the anvil assembly 110 isproperly positioned at the surgical site, the surgeon releases the anvildelivery system 50 from the anvil assembly 110 by cutting the suture“S₁” and separating the anvil assembly 110 from the second end 62 b ofthe adapter 62. The flexible tube 52 (with the fitting 62) may then bepulled from the body through the first incision “I₁”.

Severing of the suture “S₁” permits the plunger 154 to extend fromwithin the bore 164, thereby causing the finger 166 to engage the bodyportion 126 c of the cam latch member 126. Rotation of the cam latchmember 126 causes the edge 126 f of the cam latch member 126 to moveinto engagement with the inner periphery of the backup plate 120,thereby urging the head assembly 112 to return to a non-tilted operativeposition. Additionally, the distal end of the stapling device 10 may beconfigured to engage the finger 166 of the plunger 154 as the anvilassembly 110 is attached to the surgical stapling device 10. In thismanner, the distal end of the surgical stapling device 10 urges theplunger 154 distally, thereby ensuring the rotation of the head assembly112 to a non-tilted position.

With particular reference to FIG. 15, in one method, a second incision“I₂” is then formed at the surgical site such that the distal headportion 16 of surgical stapling device 10 may be received therethrough.Alternatively, the distal head portion 16 of the surgical staplingdevice 10 may be received through the first incision “I₁” once the anvildeliver system 50 has been removed from the first incision “I₁”.

Turning briefly to FIGS. 16 and 17, the anvil assembly 110 is operablyreceived on an anvil retainer 32 extending from the shell assembly 31formed on a distal end of the surgical stapling device 10. Once theanvil assembly 110 is received on the surgical stapling device 10, thesurgical stapling device 10 operates in the manner discussed in the '060patent.

The operation of the anvil assembly 110 will now be described withreference to FIGS. 18-23. When the anvil assembly 110 is in itspre-fired non-tilted position, the backup plate 120 is spaced from thebackwall 118 a of the housing 118 by the retainer 127 and theprotrusions 152 b of the center rod 152 engage the fingers 138 of thebackup plate 120 to prevent tilting of the head assembly 112 about thepivot member 162. The finger 166 of the plunger 154 is urged by thespring 156 into engagement with the body portion 126 c of the cam latchmember 126 to urge the cam latch member 126 in a clockwise direction,about the pivot member 162 such that the edge 126 f of the cam latchmember 126 engages the inner periphery 120 b of the backup member 120.

The firing of the surgical stapling device 10 causes a knife blade 33(FIG. 19) of the surgical stapling device 10 to engage the cutting ring122 to move the cutting ring 122 and backup plate 120 into annularrecess 136 of housing 118 of the head assembly 112. Arrows “W” in FIG.19 indicate how cutting ring 122 and backup plate 120 move as a resultof the firing of surgical stapling device 10. When such movement occurs,deformable tabs 127 a of retainer 127 are deformed against backwall 118a of housing 118 and fingers 138 of backup member 120 move away fromprotrusions 152 b of center rod 152. Further, inner periphery 120 b ofbackup plate 120 moves past edge 126 f of cam latch member 126 such thatcam latch member 126 is urged to pivot about pivot member 162 in thedirection indicated by arrow “X” in FIG. 21 by plunger 154 to a positionin which body portion 126 d is positioned in front of and engages backupplate 120. Engagement of plunger 154 with cam latch member 126 urges thehead assembly 112 to a second tilted position (FIGS. 22 and 23). It isnoted that the head assembly 112 will not immediately tilt upon firingof surgical stapling device 10 because, upon firing, the head assembly112 is in an approximated position, i.e., the head assembly 112 is inclose alignment with shell assembly 31 of stapling device 10, and,therefore, does not provide room for head assembly 112 to pivot. Assuch, the head assembly 112 will only begin to tilt when anvil assembly110 and shell assembly 31 of surgical stapling device 10 are beingunapproximated.

As the head assembly 112 pivots towards its forward or second tiltedposition, the finger 166 of the plunger 154 maintains the curved surface126 e of the cam latch member 126 in contact with the backup plate 120to prevent the backup plate 120 from sticking to the knife blade 33(FIG. 19) as the knife blade 33 is retracted. It is noted that thecurved surface 126 e of the cam latch member 126 is configured toeliminate any gap and ensure contact between the curved surface 126 e ofthe cam latch member 126 and the backup plate 120 to hold the backupplate 120 in place during and after the knife blade 33 is retracted suchthat the cutting ring and backup plate assembly stay in their correctposition during continued tilting of the anvil assembly 112. The anvilassembly 110 is configured such that the anvil head assembly tilts to aforward or second tilted position β degrees (FIG. 23) relative to thecenter rod assembly 114. In one embodiment, the head assembly 112 istilted about seventy degrees (70°) to its second tilted position suchthat the total pivoting movement of the head assembly 112 from theretracted or first tilted position to the forward or second tiltedposition is about one-hundred and forty degrees (140°). It should,however, be noted that the tilting of the head assembly 112 to otherdegrees is also contemplated.

As described above, the anvil assemblies of the present disclosure areconfigured to be delivered to a surgical site, e.g., the stomach “St”(FIG. 15), trans-orally. During trans-oral delivery of the anvilassemblies, a retaining suture, i.e., first suture “S₁”, retains thehead assembly of the anvil assembly in a first tilted position and aproximal guide suture, i.e., second suture “S₂”, which includes firstand second ends “S_(2a)”, “S_(2b)” that remain external of the patient'smouth “M”, permits the surgeon to dislodge or retrieve the anvilassembly 110 from the patient during trans-oral delivery.

As described above and with reference to FIG. 11, second suture “S₂” isthreaded through openings 119 b in housing 118 of head assembly 112 ofanvil assembly 110. Detaching second suture “S₂” from anvil assembly 110requires pulling on first end “S_(2a)” of second suture “S₂” such thatsecond end “S_(2b)” of second suture “S₂” travels from a locationexternally of the patient's mouth “M” (FIG. 15) where it is accessibleby the surgeon, through the patient's mouth “M” and uppergastrointestinal (GI) tract, e.g., esophagus “E” and stomach “St” (FIG.15) (collectively referred to as the patient's body lumen) and throughthe openings 119 b in housing 118 of head assembly 112 of anvil assembly110 before having to travel back through the upper GI tract and out thepatient's mouth “M”.

With reference now to FIGS. 25-33, an anvil assembly according to analternate embodiment of the present disclosure is shown generally asanvil assembly 210. The anvil assembly 210 is configured to be securedin a first tilted position (FIG. 26) for delivery and delivered using asingle suture “S” (FIG. 27). As will be described in further detailbelow, the suture “S” may be secured to anvil assembly 210 in variousconfigurations that permit detaching of the suture “S” from the anvilassembly 210 following trans-oral delivery of anvil assembly 210 using asingle cutting action and/or without creating loose pieces of the suture“S”. Further, by using the single suture “S” and securing the anvilassembly 210 in the manners described below, no portion of the suture“S” travels from the patient's mouth “M” (FIG. 15), through the upper GItract, e.g., esophagus “E” (FIG. 15) and stomach “St” (FIG. 15) duringwithdrawal. Instead, the portion of the suture “S” that does not remainattached to the anvil delivery system 50 is retracted directly from theupper GI tract and through the mouth “M”.

The various configurations for securing the anvil assembly 210 in thefirst tilted position using a single suture “S” and the methods forattaching the single suture “S” to the anvil assembly 210 in the variousconfigurations will be described as they relate to anvil delivery system50 (FIG. 11) described hereinabove; however, it is envisioned thataspects of the various configurations and methods may be modified foruse with various anvil assemblies and anvil delivery systems. It is alsoenvisioned that the methods of securing the anvil assembly 210 in thefirst tilted position described herein may be performed at any timeprior to trans-oral insertion of the anvil assembly 210, including, butnot limited to, during assembly of a kit including the anvil assembly210 and the anvil delivery system 50, or by a clinician during thesurgical procedure.

Referring initially to FIGS. 25 and 26, anvil assembly 210 issubstantially similar to anvil assembly 110 (FIG. 2) describedhereinabove, and will only be described in detail as relates to thedifferences therebetween. The anvil assembly 210 includes head assembly212 pivotally secured to a center rod assembly 214 between a firsttilted position (FIG. 26), an operative position (FIG. 25), and a secondtilted position (see, for example, anvil assembly 110 in FIG. 24). Ahousing 218 of the head assembly 212 defines first and second proximalopenings 215 a, 215 b, first and second intermediate openings 217 a, 217b, and first and second distal openings 219 a, 219 b. As will bedescribed in further detail below, each of the first and second proximaland distal openings 215 a, 215 b, 219 a, 219 b are configured to receivethe suture “S”.

Although when describing the various methods of securing the headassembly 212 using the suture “S” initial reference will be made to thefirst proximal and distal openings 215 a, 219 a of the housing 218 ofthe head assembly 212 of the anvil assembly 210, the second proximal anddistal openings 215 b, 219 b of the housing 218 are mirror images of thefirst proximal and distal openings 215 a, 219 a, therefore, thedescription of the various methods may instead refer initially to thesecond proximal and distal openings 215 b, 219 b.

FIGS. 27 and 28 illustrate a first method for securing the anvilassembly 210 in the first tilted position by tying the suture “S” in afirst configuration. With reference initially to FIG. 27, a first end“S_(a)” of the suture “S” is received into the first distal opening 219a of the housing 218 of the head assembly 212 and out of the firstproximal opening 215 a of the housing 218 before being passed throughthe first throughbore 70 of the adapter 62 of anvil delivery system 50.The first end “S_(a)” of the suture “S” is then received into the secondproximal opening 215 b of the housing 218 and out the second distalopening 219 b of the housing 218.

If the adapter 62 of the anvil delivery system 50 has not already beensecured to the center rod assembly 214 of the anvil assembly 210, theadapter assembly 62 is secured to the center rod assembly 214 byreceiving the second end 62 b of the adapter assembly 62 within a bore280 of center rod 252 of center rod assembly 214. In the first method ofsecuring the head assembly 212 of the anvil assembly 210 in the firsttilted position, the adapter 62 may be secured to the anvil assembly 210prior to or subsequent the suture “S” being received through the adapter62.

The first end “S_(a)” of the suture “S” and the second end “S_(b)” ofthe suture “S” are then crossed back over one another and pulled tight,as indicated by arrows “B” and “C”, respectively, in FIG. 27. As thefirst and second ends “S_(a)”, “S_(b)” of the suture “S” are pulledtight, the head assembly 212 of the anvil assembly 210 moves to thefirst tilted position. Alternatively, the head assembly 212 may bemanually moved to the first tilted position prior to tightening thefirst and second ends “S_(a)”, “S_(b)” of the suture “S”. Once the headassembly 212 is in the first tilted position, the first and second ends“S_(a)”, “S_(b)” of the suture “S” are crossed back over one another toform a knot “K” between the first and second distal openings 219 a, 219b of the housing 218 (FIG. 28). The knot “K” is tightened by continuoustensioning of the suture ends “S_(a)”, “S_(b)” of the suture “S” tosecure the head assembly 212 of the anvil assembly 210 in the firsttilted position.

In the first method of securing the head assembly 212 of the anvilassembly 210 in the first tilted position, the adapter assembly 62 ofthe anvil delivery system 50 may be secured to the flexible member 52 ofthe anvil delivery system 50 at any time by receiving the first end 62 aof the adapter assembly 62 with the open end 52 a of the flexible member52.

Either of the first or second ends “S_(a)”, “S_(b)” of the suture “S”may be cut adjacent the knot “K”, as indicated by line “D”, to form asingle strand of the suture “S” that extends distally from anvilassembly 210. Alternatively, the first and second ends “S_(a)”, “S_(b)”of the suture “S” may be tied together to form a loop (not shown). Thefirst and/or second ends “S_(a)”, “S_(b)” of the suture “S”, or theloop, may then be used to facilitate trans-oral insertion of the anvilassembly 210 into a patient, as described above with regards to anvilassembly 110. As detailed above, during trans-oral insertion of theanvil assembly 210, the first and/or second ends “S_(a)”, “S_(b)” of thesuture “S” remain external of the patient to permit the surgeon todislodge or retrieve the anvil assembly 210.

Once the anvil assembly 210 is received at the operative site, e.g.,within a patient, the head assembly 212 of the anvil assembly 210 may bemoved to the operative position by cutting either length of the suture“S” that extends between the first and second proximal openings 215 a,215 b of the housing 218 of the head assembly 212 and the firstthroughbore 70 in the adapter 62 of the anvil delivery system 50. Thesuture “S” may be cut at any point between the knot “K” and the adapter62. When only one of the lengths of the suture “S” that extends betweenthe first and second proximal openings 215 a, 215 b and the firstthroughbore 70 is cut, the suture “S” may be removed from the patient,in its entirety, by pulling on the first and/or second ends “S_(a)”,“S_(b)” of the suture “S”, e.g., the portion of the suture “S” thatextends from the mouth “M” of the patient. When both lengths of thesuture “S” that extend between the first and second proximal openings215 a, 215 b and the first throughbore 70 are cut, only the portion ofthe suture “S” distal of the cut is removed from the patient by pullingon the first and/or second ends “S_(a)”, “S_(b)” of the suture “S”.

FIGS. 29-31 illustrate a second method for securing the anvil assembly210 in the first tilted position by tying the suture “S” in a secondconfiguration. With reference initially to FIG. 29, a loop “L” is formedin the midpoint of the suture “S” by tying a knot “K” in the suture “S”.A first end “S_(a)” of the suture “S” is then received into the firstdistal opening 219 a of the housing 218 of the head assembly 212 of theanvil assembly 210 and out the first proximal opening 215 a of thehousing 218 while a second end “S_(b)” of the suture “S” is receivedinto the second distal opening 219 b of the housing 218 and out thesecond proximal opening 215 a of the housing. In this manner, the knot“K” formed in the suture “S” is positioned between the first and seconddistal openings 219 a, 219 b of the housing 218.

The first and second ends “S_(a)”, “S_(b)” of the suture “S” are thenreceived through the first throughbore 70 of the adapter 62 of the anvildelivery system 50 from opposite directions and then through the secondthroughbore 72 of the adapter 62 from opposite directions.Alternatively, both the first and second ends “S_(a)”, “S_(b)” of thesuture “S” may be received through the first throughbore 70 of theadapter 62 of the anvil delivery system 50 in the same direction andthen through the second throughbore 72 of the adapter 62 in the same oropposite directions.

If the adapter 62 of the anvil delivery system 50 is not already securedto the center rod assembly 214 of the anvil assembly 210, the adapter 62is secured to the center rod assembly 214, as described above. Theadapter 62 may be secured to the anvil assembly 210 prior or subsequentto the suture “S” being received through the adapter 62.

The head assembly 212 of the anvil assembly 210 may then be moved to thefirst tilted position by pulling outwardly on the portions of the suture“S” extending from the first throughbore 70 of the adapter 62, asindicated by arrows “E” and “F” in FIG. 29. Alternatively, the headassembly 212 may be moved to the first tilted position manually. Whenthe head assembly 212 is moved to the first tilted position manually,pulling on the portions of the suture “S” that extend from the firstthroughbore 70 of the adapter 62 tightens the suture “S”.

To secure the head assembly 212 of the anvil assembly 210 in the firsttilted position, the portions of the suture “S” that extend from thesecond throughbore 72 of the adapter 62, i.e., the first and second ends“S_(a)”, “S_(b)”, are pulled outwardly, as indicated by arrows “G” and“H” in FIG. 30, to tighten the suture “S” about the first end 62 a ofthe adapter 62. To maintain the suture “S” in the tightened condition,the first end 62 a of the adapter 62 is inserted within the open end 52a of the flexible member 52 of the anvil delivery system 50. As thefirst end 62 a of the adapter 62 is inserted within the open end 52 a ofthe flexible member 52, the adapter 62 is secured to the flexible member52 by a friction fit and the suture “S” is secured between the adapter62 and the flexible member 52.

In an alternative method, the first and seconds “S_(a)”, “S_(b)” of thesuture “S” are received directly from the head assembly 212 of the anvilassembly 210 through the second throughbore 72 of the adapter 62 of theanvil delivery system 50 without being received through the firstthroughbore 70 of the adapter 62. In this manner, continuous tensionmust be applied to the first and seconds “S_(a)”, “S_(b)” of the suture“S” to maintain the head assembly 212 in the first tilted position untilthe adapter 62 is secured to the flexible member 52.

Once the suture “S” is tightened and the adapter 62 of the anvildelivery system 50 is secured to the flexible member 52 of the anvildelivery system 50, the first and second ends “S_(a)”, “S_(b)” of thesuture “S” that extend from between the flexible member 52 and theadapter 62 may be trimmed. Alternatively, the first and second ends“S_(a)”, “S_(b)” of the suture “S” that extend from between the flexiblemember 52 and the adapter 62 may be wrapped around the center rodassembly 214 of the anvil assembly, around the adapter 62, and/or aroundthe flexible member 52.

During a surgical procedure in which the anvil assembly 210 istrans-orally inserted into patient, the loop “L” of the suture “S” maybe used to facilitate insertion of the anvil assembly 210 into thepatient. Alternatively, the suture “S” may be cut adjacent to the knot“K” formed in the suture “S” to form a single strand of the suture “S”that extends distally from the anvil assembly 210 and the single strandof the suture “S” may be used to facilitate insertion of the anvilassembly 210.

Once the anvil assembly 210 is received at the operative site, e.g.,within a patient, the head assembly 212 of the anvil assembly 210 ismoved to the operative position by cutting both lengths of the suture“S” that extend between the first and second proximal openings 215 a,215 b in the housing 218 of the head assembly 212 and the firstthroughbore 70 in the adapter 62 of the anvil delivery system 50. Thesuture “S” may be cut at any point between the head assembly 212 and theadapter 62. After the suture “S” is cut, the portion of the suture “S”that extends distally of the cut may be removed from the patient bypulling on the portion of the suture “S” that extends distally from thehead assembly 212.

FIG. 32 illustrates a variation to the second method for securing theanvil assembly 210 in the first tilted position using a single suture“S”, as described above. During the variation to the second method,after receiving the first and second ends “S_(a)”, “S_(b)” of the suture“S” through the housing 218 of the head assembly 212 of the anvilassembly 210, the first and second ends “S_(a)”, “S_(b)” of the suture“S” are crossed over or overlapped with one another one or more timesbefore the first and second ends “S_(a)”, “S_(b)” of the suture “S” arereceived through the first throughbore 70 of the adapter 62 of the anvildelivery system 50. In this manner, a single cut may be made to thesuture “S” along any portion of the overlapping lengths of the suture“S” to sever the suture “S”, and permit the head assembly 212 of theanvil assembly to move to the operative position.

Turning to FIG. 33, the head assembly 212 of the anvil assembly 210 isshown attached to the anvil delivery system 50 and secured in the firsttilted position using the variation of the second method describedabove. A suture reel 300 is shown supporting the portion of the suture“S” extending distally from the anvil assembly 210. An exemplary suturereel is disclosed in U.S. patent application Ser. No. 14/078,814, thecontent of which is incorporated by reference herein in its entirety.The anvil assembly 210, anvil delivery system 50 and the suture reel 300may be provided in a kit. The kit may include the anvil assembly 210secured to the anvil delivery system 50 using any of the above describedmethods in any of the above described configurations. Alternatively, thecomponents of the kit may be provided separate from one another and/orpartially assembled.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments. It is envisioned thatthe elements and features illustrated or described in connection withone exemplary embodiment may be combined with the elements and featuresof another without departing from the scope of the present disclosure.As well, one skilled in the art will appreciate further features andadvantages of the disclosure based on the above-described embodiments.Accordingly, the disclosure is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims.

1. (canceled)
 2. A method of securing a head assembly of an anvilassembly in a first tilted position, the method comprising: securing anadapter to a center rod assembly of the anvil assembly, the adapterdefining a bore; positioning a first end of a suture through a firstopening in the head assembly of the anvil assembly; positioning thefirst end of the suture through a bore in the adapter to define a firstportion of the suture that extends between the head assembly of theanvil assembly and the adapter; crossing the first end of the sutureover the first portion of the suture such that the first portion and asecond portion of the suture engage one another; positioning the firstend of the suture back through a second opening in the head assembly;and securing the first end of the suture to a second end of the sutureadjacent the head assembly to maintain the head assembly in the firsttilted position.
 3. The method of claim 2, further including pivotingthe head assembly relative to the center rod assembly to the firsttilted position prior to tying the first end of the suture to the secondend of the suture.
 4. The method of claim 2, wherein positioning thefirst end of the suture through the first opening includes positioningthe first end of the suture into a first distal opening of the headassembly and out a first proximal opening of the head assembly.
 5. Themethod of claim 4, wherein positioning the first end of the suturethrough the second opening includes positioning the first end of thesuture into a second proximal opening of the head assembly and out of asecond distal opening of the head assembly.
 6. The method of claim 2,further including securing a flexible tube to the adapter.
 7. The methodof claim 2, wherein securing the first end of the suture to the secondend of the suture adjacent the head assembly to maintain the headassembly in the first tilted position includes tying a knot in the firstand second ends of the suture.
 8. The method of claim 7, whereinsecuring the first end of the suture to the second end of the sutureincludes pivoting the head assembly to the first tilted position.
 9. Amethod of securing a head assembly of an anvil assembly in a firsttilted position, the method comprising: securing an adapter to a centerrod assembly of the anvil assembly, the adapter defining a bore;positioning a first end of a suture through a first opening in the headassembly of the anvil assembly; positioning the first end of the suturethrough a bore in the adapter to define a first portion of the suture,the first portion of the suture extending between the head assembly andthe adapter; crossing the first end of the suture over the first portionof the suture such that the first portion and a second portion of thesuture engage one another; positioning the first end of the suture backthrough a second opening in the head assembly; pivoting the headassembly relative to the center rod assembly to the first tiltedposition; and securing the first end of the suture to a second end ofthe suture adjacent the head assembly to maintain the head assembly inthe first tilted position.
 10. The method of claim 9, whereinpositioning the first end of the suture through the first openingincludes positioning the first end of the suture into a first distalopening of the head assembly and out a first proximal opening of thehead assembly.
 11. The method of claim 10, wherein positioning the firstend of the suture through the second opening includes positioning thefirst end of the suture into a second proximal opening of the headassembly and out of a second distal opening of the head assembly. 12.The method of claim 9, further including securing a flexible tube to theadapter.
 13. The method of claim 9, wherein securing the first end ofthe suture to the second end of the suture adjacent the head assembly tomaintain the head assembly in the first tilted position includes tying aknot in the first and second ends of the suture.
 14. The method of claim13, wherein securing the first end of the suture relative to the secondend of the suture includes pivoting the head assembly to the firsttilted position.
 15. A method of securing a head assembly of an anvilassembly in a first tilted position, the method comprising: positioninga first end of a suture through a first opening in the head assembly ofthe anvil assembly; positioning a second end of the suture through asecond opening in the head assembly; crossing the first and second endsof the suture over one another at least once; positioning the first andsecond ends of the suture through a first bore in an adapter of adelivery system; and securing the adapter to a flexible member of thedelivery system such that the suture is secured within the first bore tomaintain the head assembly in the first tilted position.
 16. The methodof claim 15, wherein positioning the first and second ends of the suturethrough the first bore of the adapter includes positioning the first endof the suture through the first bore of the adapter in a firstdirection, and positioning the second end of the suture through thefirst bore in a second direction.
 17. The method of claim 17, furtherincluding positioning the first end of the suture through a second boreof the adapter in the second direction, and positioning the second endof the suture through the second bore in the first direction.
 18. Themethod of claim 15, wherein securing the adapter to the flexible memberincludes positioning a first end of the adapter within an open end ofthe flexible member of the delivery system.